MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 014; PTA BALLOON DILATATION CATHETER

Catalog Number	US14150312
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultrascore 014 pta dilatation catheter was returned for evaluation.Strain relief was noted to be detached from the hub of the catheter and not returned for evaluation, and the inner guide wire lumen near to the distal end of the catheter was noted to be bunched.No other anomalies were noted during the visual evaluation.During the functional testing, the returned catheter was inflated with the in-house presto inflation and no evidence of balloon rupture was noted.Then an attempt at guide wire advancement was made, but it was not able to insert.Then another attempt was made, and it was able to be inserted with resistance near to the distal end of the balloon and while inserting through the proximal end of the balloon.No other functional testing was performed.As the returned catheter shows the evidence of strain relief detachment from the catheter and inner guide wire lumen was also noted to be bunched which was able to be observed during the visual evaluation.During the functional testing no significant evidence of balloon rupture was noted, and the in-house guide wire was inserted into the catheter with resistance.For lesion advancement, testing couldn¿t be replicated under laboratory conditions due to its condition of use.Therefore, the investigations for the reported inability to cross lesion remain inconclusive, and the investigation was unconfirmed for the reported balloon rupture and the investigation confirmed the identified strain relief detachment, inner guide wire lumen bunching and guide wire advancement issue and the reported guide wire removal issue.A definitive root cause for the reported balloon rupture, unable to cross lesion, guide wire removal failure and identified strain relief detachment, inner guide wire lumen bunching, and guide wire advancement issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 02/2024) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported during an angioplasty procedure for the tibial stenosis, the pta balloon allegedly did not track past the calcified tibial stenosis.It was further reported that the balloon was allegedly ruptured upon inflation.Furthermore, the balloon catheter allegedly became stuck on the guidewire requiring both to be removed as a single unit and the guidewire access within the target tibial lesion was lost.Reportedly, the guidewire eventually released from the catheter lumen and the balloon was subsequently removed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRASCORE 014
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18839765
• Report Number: 2020394-2024-00316
• Device Sequence Number: 18001907
• Product Code: PNO
• UDI-Device Identifier: 00801741113512
• UDI-Public: (01)00801741113512
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: US14150312
• Device Lot Number: GFGN1269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown